MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ROTATABLE CLIP FIXING DEVICE

Model Number HX-110LR

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp (omsc).The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) received a literature titled importance of second look endoscopy after per oral endoscopic myotomy for safe postoperative management".The literature reported the result of 497 patients with achalasia and esophageal motility disorders of per-oral endoscopic myotomy (poem) procedure using the olympus hx-110lr between december 2017 and september 2019.In the literature, it was reported 3 cases of intraoperative adverse events and 71 cases of abnormal findings during second look-endoscopy.Of these, 3 cases of mucosal perforation of the submucosal tunnel and failure to close the mucosal entry, 3 cases of entry site dehiscence and 2 cases of dehiscence of the mucosal perforation site due to incomplete closure may have extended hospitalization.Omsc assumes that the events might be related to the subject device since the subject device was used for the procedure.Therefore, omsc assumes that the events was an adverse event to submit.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.Omsc will submit one medical device reports (mdr) of the subject device for the adverse event.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Type of Device: ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11804519
• MDR Text Key: 249972110
• Report Number: 8010047-2021-06127
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HX-110LR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization